FDA Approves First Over-the-Counter Home Use HIV Test Kit

OraQuick In-Home HIV Test Kit.

The U.S. Food and Drug Administration has approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of HIV antibodies. The test reveals antibodies for virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). The OraQuick In-Home HIV Test is designed to allow individuals to collect an oral fluid sample by swabbing the upper and lower gums inside of their mouths, then place that sample into a developer vial, and obtain test results within 20 to 40 minutes. A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result. Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months. The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods. The Centers for Disease Control and Prevention estimates that 1.2 million people in the United States are living with HIV infection. About one in five are not aware they are infected. There are about 50,000 new HIV infections every year. Many of these new infections are transmitted from people who are unaware of their HIV status.
Share Button
Print Friendly

Filed under: Articles

Comments are closed.